Recruiting

SONATA

Sponsor:

University of Rochester

Code:

NCT07393529

Conditions

Advanced Cancer

Older Adults (65 Years and Older)

Social Networks

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

SONATA

Study Details

Brief summary:

This is a pilot randomized controlled trial to assess the feasibility, acceptability, appropriateness, and structure of the SONATA intervention. In addition, it will assess the preliminary efficacy of SONATA compared to enhanced usual care among 70 older adults with advanced cancer.

Conditions

Advanced Cancer

Older Adults (65 Years and Older)

Social Networks

Study ID

NCT07393529

Start date

Apr 10, 2026

Status verified date

Jul, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Patients

Inclusion criteria:

  • Age ≥65 years
  • A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist
  • Able to speak English
  • Able to provide informed consent

Exclusion criteria:

  • Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team
  • Unwilling to complete study procedures

Social Network Members (if available, for intervention arm only)

Inclusion criteria:

  • Age ≥18 years
  • Identified as an SN member by the patient in the intervention arm
  • Able to speak English
  • Able to provide informed consent

Exclusion criteria:

• Unwilling to complete study procedures

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: SONATA Intervention

Following randomization, patients assigned to SONATA will participate in up to six coaching sessions, delivered either in person or via Zoom over approximately six weeks.

no intervention: Enhanced Usual Care

Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization.

Interventions

SONATA

SONATA includes six evidence-based components to help patients: 1) identify and set personal goals to achieve well-being (goal-setting); 2) identify their social network (SN) members and map their SNs (network diagnostics); 3) engage key SN members to address their goals and needs (network engagement); 4) build channels for communication and collaboration with key SN members via in-person and virtual activities (opportunity creation); 5) communicate effectively with their key SN members, develop action plans, and provide support (skill building); and 6) engage in cycles of feedback to effectively respond to the patient's evolving needs.

Primary outcome measure

  • Study feasibility [ Time Frame: From baseline to week 16 ]

Central Contacts and Locations

Central contacts

Kah Poh Loh

585-276-4353Kahpoh_Loh@URMC.Rochester.edu

Becky Gravenstede

585-727-4728becky_gravenstede@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University of Rochester

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • geriatric oncology
  • social networks

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-07.